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For References, Please Put Authors and Year in the Text COXIBS ` BNF 4.7.1, 10.1.1 Class: Non-opioid analgesic, NSAID (selective COX-2 inhibitor). Indications: Coxibs available in tablet form are all licensed for use in osteo-arthritis and rheumatoid arthritis. Etoricoxib, acute gout; rofecoxib, acute pain; rofecoxib and valdecoxib, dysmenorrhoea. Parecoxib is licensed only for IM and IV use for postoperative pain. gCancer pain. Contra-indications: Known hypersensitivity to sulfonamides, inflammatory bowel disease, severe hepatic impairment (plasma albumin <25g/L or Child-Pugh score of ≥10), severe renal impairment (creatinine clearance <30ml/min), severe congestive cardiac failure (NYHA III-IV). Although active peptic ulceration is considered a contra-indication by the Committee on Safety of Medicines (UK), analgesic need may dictate the closely monitored use of a coxib. Pharmacology Coxibs selectively inhibit cyclo-oxygenase-2 (COX-2; Figure 1). They were developed specifically to reduce NSAID-induced gastroduodenal toxicity.1 However, they are not harmless,2-4 and the prevalence of serious non-gastro-intestinal effects is the same as for non-selective NSAIDs.5, 6 Chemically, celecoxib and valdecoxib contain a sulfonamide moiety, and therefore carry a risk of sulfonamide-like undesirable effects.7 In contrast, etoricoxib and rofecoxib contain a sulfone moiety, and the risk is less. © www.palliativedrugs.com August 2004 newsletter DRAFT 1.0 1 Membrane phospholipids Arachidonic acid COX-1 COX-2 PGs PGs stomach inflammation kidney (stomach) platelets kidney bone brain Figure 1 Cyclo-oxygenase (COX) and the production of prostaglandins (PGs). The degree of COX-2 selectivity varies according to the assay method used and whether the result is expressed in terms of 50% or 80% inhibition of the enzyme.8 Although 80% inhibition is theoretically a better comparator, most studies use 50% (Table 1). 8 Table 1 COX-2 selectivity ratio of IC50 COX-1/COX-2 (human whole blood assays) Drug COX-2 selectivity ratio Etoricoxib 106 Rofecoxib 35 Valdecoxib 30 Celecoxib 7.6 Nimesulide 7.3 Diclofenac 3.0 Etodolac 2.4 Meloxicam 2.0 Indometacin 0.4 Ibuprofen 0.2 Piroxicam 0.08 © www.palliativedrugs.com August 2004 newsletter DRAFT 1.0 2 Celecoxib is no more selective than nimesulide (not available in the UK), and not much more selective than meloxicam and etodolac (generally also classed as selective COX-2 inhibitors) and diclofenac (generally classed as a non-selective NSAID). However, when compared with other non-selective NSAIDs collectively, celecoxib is less gastrotoxic. 9, 10 On the other hand, when used for more than 6 months in patients with osteo-arthritis and rheumatoid arthritis, celecoxib is not significantly less gastrotoxic than diclofenac.11, 12 COX-2 is massively expressed in inflammation, and is responsible for the production of prostaglandins associated with inflammatory pain. As with non-selective NSAIDs, the coxibs exert an analgesic effect by inhibiting COX-2. In terms of efficacy in osteo- arthritis and rheumatoid arthritis, coxibs are as effective as traditional non-selective NSAIDs,2, 13 although this has been disputed.14 As yet, there are no published trials of their use in cancer pain. In contrast to non-selective NSAIDs, coxibs have little or no impact on the activity of COX-1, necessary for the production of prostaglandins associated with gastroduodenal mucosal protection and platelet function. Accordingly, none of the coxibs alters platelet function, and all are associated with a 50% or more reduction in the risk of a serious gastro-intestinal event (PUB, i.e. Perforations, symptomatic Ulcers, major gastro- intestinal Bleeding). For example, for every 100 patient-years of rofecoxib 50mg daily and naproxen 1500mg daily, there will be approximately 2 versus 4.5 PUBs (p <0.05).2 In other words, about 40 patients need to be treated with rofecoxib to avoid one PUB per annum. In some controlled trials, the incidence of PUBs is no greater than placebo.15-17 Despite gains in terms of reduced gastro-intestinal toxicity, the overall incidence of serious drug events with coxibs appears not to be reduced. 5, 6 Compared with naproxen 1500mg per day in patients with arthritis treated for a median of 9 months, rofecoxib © www.palliativedrugs.com August 2004 newsletter DRAFT 1.0 3 50mg o.d. (twice the maximum recommended dose) was associated with an excess number of cardiac ischaemic events and deaths.2 This may relate to a round-the-clock antiplatelet effect of naproxen rather than a specific prothrombotic effect of high-dose rofecoxib.18 However, in patients with arthritis, no excess of serious cardiac events has been observed with doses of 25mg o.d. or less.19, 20 In ordinary circumstances, a COX-2-dependent vasodilatory and antithrombotic prostaglandin (endothelial prostacyclin) ‘balances’ the COX-1-dependent vasoconstricting and prothrombotic prostaglandin (platelet thromboxane A2). Coxibs inhibit the production of endothelial prostacyclin, thereby leaving platelet thromboxane unopposed. In patients in whom there is a prothrombotic tendency (including many of those with cancer), a coxib may well increase the risk of a serious thrombotic event.21 The Summary of Product Characteristics (SPC) for all the coxibs emphasise this possibility. The inhibition of COX-2 also results in the loss of the prostaglandin which causes vasodilation of the renal vasculature in hypovolaemic states, thereby preserving renal function.6, 22 Coxibs can also cause fluid retention with pedal oedema, increased blood pressure (particularly in hypertensive patients),23 and congestive cardiac failure (particularly in those with ischaemic heart disease).5, 6 NSAIDs delays bone healing in laboratory animals,24, 25 and is the reason why some orthopaedic departments prohibit their use for up to 6 weeks postoperatively. The impact is greater with celecoxib and rofecoxib than with non-selective NSAIDs. In contrast, clinical studies are inconclusive.24, 25 Thus, in a study of spinal fusion in humans, the incidence of non-union was no greater with celecoxib and rofecoxib than with placebo.26 Several studies confirm that coxibs are much less likely than non-selective NSAIDs to be associated with hypersensitivity reactions in patients with known hypersensitivity to © www.palliativedrugs.com August 2004 newsletter DRAFT 1.0 4 aspirin.27-30 The concurrent administration of low-dose aspirin (325mg/day) and a coxib increases the risk of gastro-intestinal bleeding.9 For pharmacokinetic details, see Table 2. The onset of action of parecoxib ranges from 20-40min. The peak plasma concentration of its active metabolite (valdecoxib) occurs after 30-60min, and the stated duration of action is 6-12h.31 Table 2 Pharmacokinetic characteristics of coxibs 32-35 Celecoxib Etoricoxib Rofecoxib Valdecoxib Bio-availability 99% ~100% 93% 83% Onset of action ? 24min <45min <30min Time to peak 2–3h 1h 2–4h ~3h plasma concentration Plasma halflife 8–12h ~22h ~16h 8–11h Duration of action 12-24h 24h 24h 24h Cautions History of allergic-type reactions (asthma, acute rhinitis, nasal polyps, angioedema, urticaria) with aspirin or other NSAID. Other risk factors are listed in Box A. © www.palliativedrugs.com August 2004 newsletter DRAFT 1.0 5 Box A Risk factors for NSAID-induced serious gastro-intestinal event36 Age: ≥ 65 years, particularly ≥75 years Concurrent use of a corticosteroid Concurrent use of low-dose aspirin Concurrent use of anticoagulant (warfarin or heparin) Platelets <50 x 109/L Acid dyspepsia with non-selective NSAID +/- PPI or coxib now or in past Peptic ulcer in last year confirmed by endoscopy Gastro-intestinal haemorrhage in last year confirmed by endoscopy, or strong clinical suspicion, e.g. haematemesis, melaena. Patients already receiving warfarin should have their INR closely monitored during the first week after starting treatment with a coxib; increases of up to 60% have been reported.3, 37 Patients with hypertension23 and with cardiac, hepatic or renal impairment may deteriorate, and should be monitored appropriately. Except in patients expected to die in a few days, dehydrated patients should be rehydrated when starting treatment with a coxib (or other NSAID). Important drug interactions NSAIDs, including coxibs, decrease the renal excretion of lithium. Coxibs may reduce the renal clearance of methotrexate. Cytochrome P450 Celecoxib: predominantly metabolised by CYP2C9; in patients receiving fluconazole (but not ketoconazole), the dose of celecoxib should be halved. Inducers of CYP2C9 © www.palliativedrugs.com August 2004 newsletter DRAFT 1.0 6 (e.g. barbiturates, carbamazepine, rifampicin) may reduce plasma concentrations of celecoxib. Celecoxib inhibits CYP2D6 and may lead to increased plasma concentrations of beta-adrenoceptor antagonists,38 tricyclic antidepressants, SSRIs, antipsychotics, and dextromethorphan. Etoricoxib: metabolised mainly by CYP3A4, and plasma concentrations may be increased if co-administered with ketoconazole (but not fluconazole). CYP1A2, CYP2D6, CYP2C9 and CYP2C19 may also be involved. Rifampicin reduces the plasma concentration of etoricoxib by about 2/3. Rofecoxib: metabolised mainly by reduction to dihydrorofecoxib and is therefore independent of the cytochrome P450 system. However, potent inducers of cytochrome P450 (e.g. barbiturates, carbamazepine, rifampicin) activate an alternative metabolic pathway. Thus, rifampicin reduces the plasma concentration of rofecoxib by about 1/2. Valdecoxib (and parecoxib): metabolised mainly via CYP2C9 and CYP3A4. Plasma exposure (AUC) is increased by nearly
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